NEW YORK, Dec. 9, 2015 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device
company focused on oncology with an emphasis on the treatment of
primary and metastatic liver cancers, announces that the results
from its Phase 3 clinical study of the Delcath Hepatic Delivery
System (Melphalan/HDS) for the treatment of melanoma patients with
liver metastases, have been published in the December issue of the
prestigious, peer-reviewed journal, Annals of Surgical
Oncology. The study completed enrollment in 2009 and used an
earlier version of the Melphalan/HDS and procedure. Melphalan/HDS
is investigational in the United
States.
The study, "Results of a Randomized Controlled Multi-Center
Phase III Trial of Percutaneous Hepatic Perfusion (PHP) Compared to
Best Available Care for patients with Melanoma Liver
Metastases," by lead investigator and senior author
James F. Pingpank, Jr., M.D.,
Associate Professor of Surgery at the University of Pittsburgh Medical Center, and first
author Marybeth S. Hughes, M.D.,
Center for Cancer Research, National Cancer Institute, et
al., compared patients randomly assigned to receive PHP
treatments with melphalan using the Melphalan/HDS, or best
alternative care (BAC). Patients assigned to the PHP arm were
eligible to receive up to six cycles of treatment at approximately
four to eight week intervals. Patients randomized to the BAC arm
were permitted to cross-over into the PHP arm at radiographic
documentation of hepatic disease progression; a majority of the
patients in the BAC arm did, in fact, cross over to the PHP arm.
Patients who received PHP were given stem cell support in the form
of platelet and red blood cell infusions to mitigate toxic side
effects of melphalan. The study's primary endpoint was hepatic
progression-free survival (hPFS); secondary endpoints included
overall progression free survival (oPFS), overall survival (OS),
hepatic objective response rate (hOR), and safety.
In the 93 patient study, results showed that patients in the PHP
arm had a statistically significant longer median hPFS of 7.0
months compared to 1.6 months in the BAC control group, according
to independent imaging review. Median oPFS was 5.4 months vs.
1.6 months for BAC, according to investigator assessment. Median OS
for PHP was 10.6 months vs. 10 months for BAC; sub-group analysis
revealed that OS among BAC patients who had crossed over to receive
PHP was 13.1 months. The hOR was 36.4% for PHP vs. 2% for
BAC. With the inclusion of patients with stable disease, overall
hepatic disease control rates were 75% for PHP vs. 42.9% for
BAC.
The most common post-procedure adverse events (AEs) were related
to grade 3 and 4 bone marrow suppression, and included neutropenia
(85.7%), thrombocytopenia (80%) and anemia (62.9%). Investigators
attributed three deaths to treatment with PHP. An additional death
resulting from a gastric perforation occurred in a patient that
crossed-over to the PHP arm.
Investigators concluded that the study "demonstrated improved
control of liver disease" in patients treated with Melphalan/HDS,
and that the "benefit extended to oPFS", suggesting a clear
clinical benefit to disease control in the liver in the patient
population. Investigators noted that the earlier version of the
Melphalan/HDS and PHP procedure utilized in the study was
associated with significant morbidity, and recommended
modifications such as the use of prophylactic bone marrow growth
factors that are already required in the clinical studies that
comprise Delcath's current Clinical Development Program in the
treatment of primary and metastatic liver cancers.
"Publication of the results of our prior Phase 3 trial in such a
prestigious journal is a key milestone for Delcath, and underscores
the importance of these data in this area of unmet medical
need. In addition, it provides us with an important tool that
will enhance our efforts to expand reimbursement in certain
European countries," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and Chief Executive
Officer of Delcath. "Since enrollment in this study was concluded
in 2009, the number of treatments administered with the enhanced
Melphalan/HDS product and procedure utilized commercially in
Europe have exceeded the number
treated during the trial. The more recent data from European
experience presented at several medical congresses this fall
provide us with confidence that an improved safety profile can be
demonstrated in the new, pivotal global trial we expect to launch
in the coming weeks."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology with a principal focus on the
treatment of primary and metastatic liver cancers. Our proprietary
Melphalan Hydrochloride for Injection for use with the Delcath
Hepatic Delivery System (Melphalan/HDS) is designed to administer
high-dose chemotherapy to the liver while controlling systemic
exposure. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under the trade name
Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).
In the U.S. the Melphalan/HDS system is considered a combination
drug and device product, and is regulated as a drug by the U.S.
Food and Drug Administration (FDA). Melphalan/HDS has not been
approved for sale in the U.S. We have commenced a global Phase 2
clinical trial in Europe and the
U.S. to investigate the Melphalan/HDS system for the treatment of
primary liver cancer (HCC) and intrahepatic cholangiocarcinoma
(ICC), and expect to initiate a global Phase 3 trial in ocular
melanoma (OM) that has metastasized to the liver and plan to
evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2
clinical study.
Private Securities Litigation Reform Act of 1995 provides a
safe harbor for forward-looking statements made by the Company or
on its behalf. This news release contains forward-looking
statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: the impact, if any, of
publication of the Phase 3 trial manuscript to support the
Company's efforts, the timing and results of the
Company's clinical trials including without limitation the
HCC, ICC and OM clinical trial programs timely
enrollment and treatment of patients in the global Phase 2 HCC and
ICC clinical trial, FDA approval of the global Phase 3 OM clinical
trial protocol, IRB or ethics committee clearance of the Phase 2
HCC/ICC and/or Phase 3 OM protocols
from participating sites and the timing of site activation and
subject enrollment in each trial, the impact of the presentations
at major medical conferences and future clinical results consistent
with the data presented, approval of Individual Funding Requests
for reimbursement of the CHEMOSAT procedure, the impact, if
any of ZE reimbursement on potential CHEMOSAT product use and
sales in Germany, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system
to deliver and filter melphalan in Europe including the key markets of
Germany and the UK, the Company's
ability to successfully commercialize the Melphalan HDS/CHEMOSAT
system and the potential of the Melphalan HDS/CHEMOSAT system as a
treatment for patients with primary and metastatic disease in the
liver, our ability to obtain reimbursement for the CHEMOSAT system
in various markets, the Company's ability to satisfy the
requirements of the FDA's Complete Response Letter and provide the
same in a timely manner, approval of the current or future
Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets, actions by the FDA or other
foreign regulatory agencies, the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same,
uncertainties relating to the timing and results of research and
development projects, our ability to maintain NASDAQ listing, and
uncertainties regarding the Company's ability to obtain financial
and other resources for any research, development, clinical trials
and commercialization activities. These factors, and others, are
discussed from time to time in our filings with the Securities and
Exchange Commission. You should not place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. We undertake no obligation to publicly update or revise
these forward-looking statements to reflect events or circumstances
after the date they are made.
Contact Information:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.